MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-13 for TERUFLEX BLOOD BAG SYSTEM 3BO356E8 manufactured by Terumo Bct, Ltd.
| Report Number | 3001980567-2020-00065 |
| MDR Report Key | 9706587 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-08-08 |
| Date Added to Maude | 2020-02-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ALAN MCGAHIE |
| Manufacturer Street | OLD BELFAST ROAD |
| Manufacturer City | LARNE BT4025H |
| Manufacturer Country | UK |
| Manufacturer Postal | BT40 25H |
| Manufacturer Phone | 4282827363 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERUFLEX BLOOD BAG SYSTEM |
| Generic Name | TRIPLE TB CPD/AS-5 350ML ENG |
| Product Code | CAK |
| Date Received | 2020-02-13 |
| Catalog Number | 3BO356E8 |
| Lot Number | 190808C151 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO BCT, LTD |
| Manufacturer Address | LARNE UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-13 |